Study on Prescribers' Knowledge and Understanding of Safety Messages Following Dengvaxia® Product Information Update

Dengue Virus Infection Clinical Trial

— DNG00042  

Official title:

A Cross-sectional Survey to Evaluate Prescribers' Knowledge and Understanding of Safety Messages Following Dengvaxia® Product Information Update

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04170140
• Other study ID #: DNG00042
• Secondary ID: U1111-1233-9599
• Status: Completed
• Start date: January 7, 2020
• Est. completion date: March 5, 2020

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of the study is to evaluate the effectiveness of additional risk minimization measures material by assessing the knowledge and understanding of healthcare professionals regarding the key safety messages provided in the material. The secondary objective of the study is to evaluate if healthcare professionals know Dengvaxia product information, namely, age indication and contraindications.

Description:

The study is a cross-sectional Survey. Study data are collected through a questionnaire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 5, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

• Healthcare professionals who are current or past prescribers of Dengvaxia

Exclusion criteria:

• Healthcare professionals who have never prescribed Dengvaxia
• Healthcare professionals who may have a conflict of interest with the survey (i.e. Healthcare professionals employed by regulatory bodies, pharmaceutical industries)
• Healthcare professionales who have participated in testing the questionnaire for comprehensibility, consistency and the appropriateness of medical terms The above information is not intended to contain all considerations relevant to participation in the survey.

Related Conditions & MeSH terms

• Dengue Virus Infection

Intervention

Other:
• No intervention
Questionnaire

Locations

Country	Name	City	State
France	Real World Evidence Solutions IQVIA	La Defense

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

France, 

References & Publications (1)

Almas MF, Toussi M, Valero E, Moureau A, Marcelon L. A cross-sectional survey to evaluate prescribers' knowledge and understanding of safety messages following Dengvaxia(R) product information update. Pharmacoepidemiol Drug Saf. 2022 Jul;31(7):758-768. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthcare professionals' knowledge and understanding of key safety messages provided in risk minimization measures materials	Knowledge and understanding of key safety messages are assessed through a questionnaire	Day 0
Secondary	Healthcare professionals' knowledge of Dengvaxia product information	Knowledge of Dengvaxia product information (age indication and contraindications) is assessed through a questionnaire	Day 0